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Regulatory Perspective on Real Time Release Testing RTRT Fda Form

Regulatory Perspective on Real Time Release Testing RTRT Fda Form

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thanks raphael for the excellent presentation on the state of pharmaceutical quality now i'm going to present what fda has done to successfully facilitate the implementation of advanced manufacturing for pharmaceutical development and production why is advanced manufacturing important from our perspective we believe that advanced manufacturing will further enhance our ability to reliably deliver quality job products over the life cycle it will enable flexible and agile manufacturer of high quality drugs without extensive quality oversight furthermore advanced manufacturing supports new clinical development to meet a met patient nics and shorter cmc development timelines therefore we fda strongly supports the use of advanced manufacturing and believe that it is key to improve our capability in response to public health crisis epidemic in this presentation i will discuss our effort in facilitating the adoption of continuous manufacturing because this technology is a key example o

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